BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7104810 · Received December 11, 2017

    Report

    Report Number
    3004209178-2017-25743
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    January 28, 2016
    Report Date
    February 20, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2018 (B)(6). IT WAS REPORTED THAT MAYBE SCAR TISSUE WAS MAKING THE INS NOT AS POWERFUL. THE PATIENT HAD NOT YET BEEN EVALUATED BY THEIR HEALTHCARE PROVIDER CONCERNING NOT FEELING THE ¿ZING.¿ THE PATIENT REPORTED THAT NOW THEY FEEL IT ON B AND IF THEY LIFT THEIR ARMS WHILE LYING DOWN. THE PATIENT REPORTED THEY WOULD REACH OUT TO THEIR MANUFACTURER REPRESENTATIVE. IT WAS A BUMMER THAT THEIR LEAD WAS NOT ABLE TO COVER THEIR NECK AND CHEST PAIN, BUT IT HELPED THEIR BUTT PAIN. THE RIGHT LEG PAIN PASSES RIGHT THROUGH. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME- OTHER. IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANT SINCE (B)(6) 2016 AND SINCE THEN THEY COULD NOT LAY DOWN ON PROGRAM D BECAUSE IT ¿ZINGS¿ THEM. THE PATIENT STATED THAT THEY USUALLY LAY DOWN ON PROGRAM B. HOWEVER, THEY STATED LAST NIGHT, (B)(6) 2017, THE PATIENT LAID DOWN ON PROGRAM D AND THE DID NOT FEEL THE ¿ZING¿ THAT THEY USED TO. THE PATIENT STATED THAT THEY THOUGHT THIS WAS KIND OF WEIRD. THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP) TO ADDRESS THEIR REPORTED ISSUE. THE PATIENT INDICATED THAT THEY WERE SUPPOSED TO SEE THEIR HCP AFTER THEIR HYSTERECTOMY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885093 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR